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The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adolescents

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ClinicalTrials.gov Identifier: NCT02499705
Recruitment Status : Terminated (Prematurely unblinded based on outcome in other trial. 2 out of 3 particpants in one arm had clinically elevated fasting insulin. Adverse event was reported.)
First Posted : July 16, 2015
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
The purpose of this study is to investigate the effects of dietary exposure to artificial sweeteners on taste sensitivity, preference and brain response in adolescents using fMRI, psychophysical measures, and questionnaires. The investigators hypothesize that dietary exposure to artificial sweeteners (sucralose) will decrease sensitivity to taste, shift preference of sweet and savory taste to a higher dose, and reduce brain response in amygdala to sweet taste compared to sucrose.

Condition or disease Intervention/treatment Phase
Insulin Resistance Obesity Dietary Supplement: Sucralose Dietary Supplement: Sucrose Dietary Supplement: Sucralose + maltodextrin Not Applicable

Detailed Description:
We aim to identify neural factors that contribute to taste intensity perception in humans and to determine environmental mechanisms that contribute to variation in taste sensitivity. Significant controversy surrounds the possibility that consumption of artificial sweeteners (AFS) leads to weight gain. Given that the five FDA approved AFSs are found in thousands of foods (Yang 2010) this marks a clear and significant gap in knowledge. Our preliminary data demonstrate a 3-fold decrease in sweet taste sensitivity following consumption of a beverage sweetened with two packets of Splenda for just 10 days. These data provide strong evidence that repeated exposure to sucralose reduces perception of sweet taste intensity, most likely by down-regulation of the sweet taste receptor. Adolescents may be more sensitive to exposure to AFS because of changes in metabolism during this period of development. Physiologic insulin resistance occurs during adolescence (Moran, Jacobs et al. 1999); this change in insulin sensitivity may predispose adolescents to greater impairments in sweet taste intensity by altering the relationship between sweet taste and post-ingestive reward, as suggested by the Davidson and Swithers model (Davidson and Swithers 2004). Therefore, it is imperative that we gain a greater understanding of the physiological consequences of AFS use in adolescents, since alterations in sweet taste perception, metabolism and brain reward that occur in response to AFS exposure may promote weight gain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adolescents
Study Start Date : November 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Sucrose

Arm Intervention/treatment
Experimental: Sucralose
Flavored beverage with sucralose.
Dietary Supplement: Sucralose
2 packets

Experimental: Sucrose
Flavored beverage with sucrose.
Dietary Supplement: Sucrose
equisweet to sucralose

Experimental: Sucralose + maltodextrin
Flavored beverage with Splenda + maltodextrin .
Dietary Supplement: Sucralose + maltodextrin
sucralose plus equicaloric (to sucrose) maltodextrin




Primary Outcome Measures :
  1. Ratings of taste sensitivity [ Time Frame: on average 2 weeks ]
    At baseline and after on average 2 weeks, subjects will rate intensity of sucrose, sucralose, mono potassium glutamate, sodium chloride and citric acid using the General Labeled Magnitude Scale (gLMS). It is a vertical line with quasi-logarithmic spaced labels that start at the bottom with 'barely detectable' to 'strongest imaginable' at the top, recoded to 0-100.


Secondary Outcome Measures :
  1. Insulin resistance and GLP-1 [ Time Frame: on average 2 weeks ]
    We will draw a blood sample to assess glucose, insulin and GLP-1

  2. Ad libitum food intake [ Time Frame: on average 2 weeks ]
    Subject is offered milk and cereal and asked to consume as much as they want. The amount consumed is measured in weight and converted to calories.

  3. percent signal change of brain response in reward and gustatory areas to taste stimuli [ Time Frame: on average 2 weeks ]
    brain response in reward and gustatory areas to sucrose, mono potassium glutamate, sodium chloride and citric acid (in percent signal change).



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Fluent in English
  • Right handed
  • 13-17 years old

Exclusion Criteria:

  • History of oral nerve damage, presence of known taste or smell disorder, food allergies or sensitivities (for example nuts, lactose, artificial sweeteners), history of CNS disease, diabetes, history of DSM-IV major psychiatric disorder, including alcohol and substance abuse, chronic use of medication that may affect taste, conditions that may interefere with gustatory or olfactory perception (colds, seasonal allergies, recent smoking history), aberrant stimulus ratings, contra-indication for fMRI, uncomfortable swallowing in supine position, discomfort or anxiety associated with insertion an intravenous catheter, regular artificial sweetener use.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499705


Locations
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United States, Connecticut
The John B. Pierce Laboratory
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Dana M Small, PhD The John B. Pierce Laboratory/Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02499705    
Other Study ID Numbers: 1409014612
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases